Effect on Cognitive Performance and Safety/Tolerability of SSR180711C in Mild Alzheimer's Disease

This study has been terminated.
(Insufficient expected benefit risk)
Information provided by:
ClinicalTrials.gov Identifier:
First received: January 16, 2008
Last updated: July 17, 2009
Last verified: July 2009
The primary objective of the study is to assess the effect of 3 doses of SSR180711C on cognitive performance in patients with mild Alzheimer's Disease (AD). Other objectives are to assess the safety/tolerability of SSR180711C in patients with mild AD.

Condition Intervention Phase
Alzheimer's Disease
Drug: SSR180711C
Drug: donepezil
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-blind, Parallel-group, Placebo-controlled Study of the Effect on Cognitive Performance and Safety/Tolerability of SSR180711C for 4 Weeks, Using Donepezil as Calibrator, in Patients With Mild Alzheimer's Disease

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change in cognitive performance [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognitive, global, functional and behaviorial assessments [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: January 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
dose 1
Drug: SSR180711C
duration of treatment: 4 weeks
Experimental: 2
dose 2
Drug: SSR180711C
duration of treatment: 4 weeks
Experimental: 3
dose 3
Drug: SSR180711C
duration of treatment: 4 weeks
Placebo Comparator: 4 Drug: placebo
duration of treatment: 4 weeks
Active Comparator: 5 Drug: donepezil
duration of treatment: 4 weeks


Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Outpatients with diagnosis of mild AD

Exclusion Criteria:

  • Concomitant or previous treatment by acetylcholinesterase inhibitors and/or memantine
  • Medical condition which may interfere with the study
  • History of epileptic seizures
  • Lens opacity
  • Lack of reliable caregiver

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00602680

Sanofi-Aventis Administrative Office
Paris, France
Sponsors and Collaborators
Study Chair: Bruno DUBOIS, MD Scientific Advisory Committee
  More Information

Responsible Party: ICD study director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00602680     History of Changes
Other Study ID Numbers: PDY10400  SSR180711  EudraCT 2007-001639-80 
Study First Received: January 16, 2008
Last Updated: July 17, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sanofi:

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Mental Disorders
Nervous System Diseases
Neurocognitive Disorders
Neurodegenerative Diseases
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nootropic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 24, 2016